Clearance Summary
UL UHD-Clear View 4K Camera System (UL-3Chip 4K) received FDA 510(k) clearance under submission number K250462, sponsored by Univlabs Technologies Private Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-08-11.
- Submission: K250462
- Applicant / Sponsor: Univlabs Technologies Private Limited
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2025-08-11
Classification & Regulation
This clearance is catalogued under FDA product code FET and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.